Loseasonique label

Loseasonique

Loseasonique Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

LoSeasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy.

History

There is currently no drug history available for this drug.

Other Information

LoSeasonique (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets provide an oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol.

The structural formulas for the active components are:

Structural formula of levonorgestrel

Levonorgestrel C21H28O2 MW: 312.4

Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-.

Structural formula of ethinyl estradiol

Ethinyl Estradiol C20H24O2 MW: 296.4

Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.

Inactive ingredients for the orange tablets include FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin.

Inactive ingredients for the yellow tablets include anhydrous lactose, FD&C Yellow # 10 aluminum lake, FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.

Loseasonique Manufacturers

  • Physicians Total Care, Inc.
    Loseasonique | Physicians Total Care, Inc.
    No Recall

    Loseasonique | Physicians Total Care, Inc.

    Loseasonique | Physicians Total Care, Inc.

    Take one tablet by mouth at the same time every day. The dosage of LoSeasonique  is one orange tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, LoSeasonique must be taken exactly as directed and at intervals not exceeding 24 hours.

    Instruct the patient to begin taking LoSeasonique on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first orange tablet is taken that day. One orange tablet should be taken daily for 84 consecutive days, followed by one yellow tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until an orange tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the yellow tablets are taken.

    Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of LoSeasonique, following the same schedule: 84 days taking an orange tablet followed by 7 days taking a yellow tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken an orange tablet daily for 7 consecutive days.

    If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.

    For patient instructions regarding missed pills, see PATIENT COUNSELING INFORMATION (17.2).

    For postpartum women who are not breastfeeding, start LoSeasonique no earlier than four to six weeks postpartum. If the patient starts on LoSeasonique postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken an orange tablet for 7 consecutive days.

  • Teva Women’s Health, Inc.
    Loseasonique | Teva Women's Health, Inc.
    No Recall

    Loseasonique | Teva Women's Health, Inc.

    Loseasonique | Teva Women's Health, Inc.

    Take one tablet by mouth at the same time every day. The dosage of LoSeasonique  is one orange tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, LoSeasonique must be taken exactly as directed and at intervals not exceeding 24 hours.

    Instruct the patient to begin taking LoSeasonique on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first orange tablet is taken that day. One orange tablet should be taken daily for 84 consecutive days, followed by one yellow tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until an orange tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the yellow tablets are taken.

    Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of LoSeasonique, following the same schedule: 84 days taking an orange tablet followed by 7 days taking a yellow tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken an orange tablet daily for 7 consecutive days.

    If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.

    For patient instructions regarding missed pills, see PATIENT COUNSELING INFORMATION (17.2).

    For postpartum women who are not breastfeeding, start LoSeasonique no earlier than four to six weeks postpartum. If the patient starts on LoSeasonique postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken an orange tablet for 7 consecutive days.